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Devices
Device Recall Abbott Diabetes Care, Precision Xtra
모델명 / 제조번호(시리얼번호)
Lot codes: 45001A330, 45001A467, 45001A481, 45001A482, 45001A483, 45001A487, 45001A488, 45001A496, 45001A497, 45001A499, 45001A500, 45001A503, 45001A505, 45001A506, 45001A510, 45001A511, 45001A513, 45001A519, 45001A520, 45001A521, 45001A530, 45001A532, 45001A534, 45001A536, 45001A537, 45001A545, 45001A556, 45001A565, 45001A566, 45001A568, 45001A573, 45001A577, 45001A584, 45001A594, 45001A595, 45001A597, 45001A605, 45001A607, 45001A608, 45001A609, 45001A613, 45001A614, 45001A626, 45001A634, 45001A637, 45001A641, 45001A644, 45001A645, 45001A656, 45001A660, 45001A664, 45001A669, 45001A670, 45001A671, 45001A677, 45001A678, 45001A682, 45001A685, 45001A694, 45001A700, 45001A705, 45001A706, 45001A707, 45001A709, 45001A712, 45001A730, 45001A732, 45001A739, 45001A742, 45001A744, 45001A751, 45001A753, 45001A757, 45001A762, 45001A777, 45001A778, 45001A786, 45001A788, 45001A790, 45001A798, 45001A806, 45001A814, 45001A815, 45001A816, 45001A820, 45001A840, 45001A842, 45001A847, 45001A852, 45001A856, 45001A860, 45001A861, 45001A872, 45001A876, 45001A882, 45001A910, 45001A912, 45001A914, 45001A918, 45001A920, 45001A921, 45001A940, 45001A947, 45001A948, 45001A949, 45001A971, 45001A976, 45001A979, 45001A982, 45001A983, 45001C008, 45001C011, 45001C012 45384, 45388, 45396, 45407, 45418, 45455, 45456, 45463, 45464, 45512, 45514, 45516, 45521, 45611, 45612, 45614, 45619, 45627, 45632, 45639, 45645, 45646, 45653, 45670, 45679, 45680, 45682, 45707, 45708, 45724, 45729, 45731, 45732, 45733, 45735, 45737, 45738, 45755, 45777, 45782, 45783, 45784 Precision Xtra Blood Glucose & Ketone Monitoring System: 01P107D, 01P128D, 01P139D, 02P140D, 01P153D, 02P201D, 02P223D, 02P229D, 03P107D, 03P155D, 03P158D, 03P194D, 03P209D, 03P222D, 03P223D, 03P242D, 04P154D, 04P194D, 04P201D, 04P315D, 05P106D, 05P107D, 05P127D, 05P130D, 05P138D, 05P139D, 05P140D, 05P152D, 05P201D, 06P180D, 06P322D, 07P141D, 08P106D, 08P138D, 08P279D, 09P106D, 09P140D; Precision G3b Smartblue Blood Glucose Test Strips: 45001A710.
의료기기 분류등급
Clinical Chemistry and Clinical Toxicology Devices
의료기기 등급
2
이식된 장치?
No
유통
Products were released for distribution in US and Puerto Rico.
제품 설명
Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; || Precision Xtra Blood Glucose & Ketone Monitoring System; || Precision G3b Smartblue Blood Glucose Test Strips;
Manufacturer
Abbott Diabetes Care, Inc.
1 Event
Device Recall Abbott Diabetes Care, Precision Xtra 의 리콜
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제조사
Abbott Diabetes Care, Inc.
제조사 주소
Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
Source
USFDA
Language
English
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